Clinical Monitoring Research Program Directorate, Clinical Research Directorate, Frederick National Laboratory for Cancer Research sponsored by the National Cancer Institute, Frederick, Maryland, USA.
Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Maryland, USA.
Clin Infect Dis. 2020 Aug 14;71(4):1017-1021. doi: 10.1093/cid/ciz880.
After scale-up of antiretroviral therapy (ART), routine annual viral load monitoring has been adopted by most countries, but reduced frequency of viral load monitoring may offer cost savings in resource-limited settings. We investigated if viral load monitoring frequency could be reduced while maintaining detection of treatment failure.
The Rakai Health Sciences Program performed routine, biannual viral load monitoring on 2489 people living with human immunodeficiency virus (age ≥15 years). On the basis of these data, we built a 2-stage simulation model to compare different viral load monitoring schemes. We fit Weibull regression models for time to viral load >1000 copies/mL (treatment failure), and simulated data for 10 000 individuals over 5 years to compare 5 monitoring schemes to the current viral load testing every 6 months and every 12 months.
Among 7 monitoring schemes tested, monitoring every 6 months for all subjects had the fewest months of undetected failure but also had the highest number of viral load tests. Adaptive schemes using previous viral load measurements to inform future monitoring significantly decreased the number of viral load tests without markedly increasing the number of months of undetected failure. The best adaptive monitoring scheme resulted in a 67% reduction in viral load measurements, while increasing the months of undetected failure by <20%.
Adaptive viral load monitoring based on previous viral load measurements may be optimal for maintaining patient care while reducing costs, allowing more patients to be treated and monitored. Future empirical studies to evaluate differentiated monitoring are warranted.
抗逆转录病毒疗法(ART)扩大规模后,大多数国家都采用了常规的年度病毒载量监测,但在资源有限的情况下,减少病毒载量监测的频率可能会节省成本。我们研究了在维持治疗失败检测的情况下,是否可以降低病毒载量监测的频率。
Rakai 健康科学项目对 2489 名人类免疫缺陷病毒(年龄≥15 岁)感染者进行了常规的、每半年一次的病毒载量监测。在此基础上,我们构建了一个两阶段模拟模型,以比较不同的病毒载量监测方案。我们对病毒载量>1000 拷贝/ml(治疗失败)的时间进行了威布尔回归模型拟合,并对 10000 名个体进行了 5 年的模拟数据比较,以比较 5 种监测方案与目前每 6 个月和每 12 个月进行一次病毒载量检测的方案。
在测试的 7 种监测方案中,所有受试者每 6 个月监测一次的方案漏检失败的月数最少,但病毒载量检测次数也最多。使用以前的病毒载量测量结果来告知未来监测的适应性方案显著减少了病毒载量检测次数,而没有明显增加漏检失败的月数。最佳的适应性监测方案使病毒载量测量减少了 67%,同时将漏检失败的月数增加了不到 20%。
基于以前的病毒载量测量结果的适应性病毒载量监测可能是在维持患者护理的同时降低成本的最佳选择,从而可以治疗和监测更多的患者。需要进行未来的实证研究来评估差异化监测。